New treatments for Fuchs' dystrophy
Fuchs’ dystrophy is the leading cause of corneal transplants. For over two decades, we have pioneered and optimized DSEK and DMEK transplant procedures. Next we hope to prevent the need for corneal transplants in the future, and we have several research studies underway working toward this goal.
Recently, we began a Natural History Study to take a detailed look at eyes affected with Fuchs’
dystrophy to evaluate natural disease progression before a transplant to understand how the cornea
changes over time. The aim of this study is to determine the best time to begin a preventative eye drop
treatment.
The next phase of this research is evaluating an investigational eye drop that targets the gene variant
most often associated with Fuchs’ dystrophy (flyer below). This new study evaluates safety, tolerability, and the impact of corneal endothelium biomarkers in patients who are diagnosed with Fuchs’ dystrophy and scheduled for a transplant.
Please note: For this study enrollment is full and data collection is ongoing. Check back for updates.
Impact of donor diabetes on transplant success
Dr. Marianne Price is Co-Chairing a National Eye Institute sponsored study that will evaluate whether diabetes in an organ and tissue donor affects DMEK success. Currently, 30% of the corneas transplanted in the U.S. come from donors who had diabetes. This study evaluated the results of 1,400 DMEK cases performed at 27 sites across the nation. All patients have completed 1-year follow up and we plan to follow a subset of patients out to 5 years.
Impact of donor tissue treatment on transplant success
If the endothelial cells lining the inner surface of someone’s cornea become dysfunctional, we can
replace them with healthy donor tissue using a transplant procedure known as DMEK. Some of the
donor cells are typically lost during the transplant procedure, so we are doing a study to determine
whether we can minimize cell loss by briefly incubating the donor tissue in growth factors at the time of
the transplant procedure.
Corneal strengthening treatment for keratoconus
Keratoconus is a condition that causes thinning and bulging of the cornea, which distorts vision. We participated in studies leading to FDA approval of “crosslinking” to strengthen the cornea to prevent keratoconus progression. We are conducting a randomized trial to determine whether the 30 minute treatment can be shortened to 10 minutes toease the patient experience and still be effective.
Corneal neovascularization
The cornea is the clear window on the front of the eye and is the only area of the body that does not have any blood vessels. Sometimes abnormal blood vessels grow into the cornea because of infection, contact lens wear, immunologic diseases or other eye problems. The abnormal vessels can lead to scarring, swelling, and persisstent inflammation, and significantly impair vision and quality of life. We are evaluating use of corneal crosslinking to treat this sight-threatening condition. Our preliminary results are encouraging.
Corneal scarring
A corneal injury or Infection can lead to scarring that impairs vision. We are participating in a study to
determine whether use of a novel growth factor, administered as an eye drop, can help reduce corneal
scar formation in patients who have suffered recent corneal trauma or infection.
Corneal ulcers - CapriCORN study
We are collaborating with other centers around the world identify pathogens and molecular markers
that may be important to the clinical outcome in patients with corneal ulcers. This study, which is
named “Comprehensive Analysis of Pathogens, Resistomes, and Inflammatory-markers in the CORNea”
(capriCORN), uses a powerful tool called metagenomics deep sequencing to test for infectious agents,
such as bacteria, virus, or other parasites, and assess antibiotic resistance markers in samples taken
from patients with corneal ulcers.
Limbal stem cell deficiency
Normally, the outer layer of the cornea is replenished by cells known as limbal stem cells, but certain
conditions can cause limbal stem cell loss or dysfunction, resulting in pain, inflammation, redness,
scarring and breakdown of the corneal surface. We are participating in a study to determine whether
the use of growth factor eye drops can improve vision and restore a more normal corneal surface in
patients with limbal stem cell deficiency.
Eye drops for presbyopia
As we age, the lens inside our eye has more difficulty fully adjusting to help us see up close; this is called
presbyopia. We participated in the clinical studies that resulted in the first eye drop approved to treat
presbyopia (Vuity®) to preserve our ability to see up close and avoid the need for reading glasses. We
are currently evaluating a different eye drop formulation designed to have a longer effect.
Intraocular lens for presbyopia
We are evaluating a presbyopia-correcting intraocular lens that can be implanted at the time of cataract
surgery to provide extended depth of focus using a small aperture design. In addition to minimizing the
need for reading glasses, the small aperture lens can help reduce visual distortion in patients who have
corneal aberrations or irregularities.
Descemet's Stripping Only
For patients with early- to mid-stage Fuchs’ dystrophy, an alternative to DMEK or DSAEK is for your surgeon to remove a small area of unhealthy central endothelium and Descemet membrane using a technique known as DSO / DWEK. Rather than implanting donor corneal tissue, which generally provides visual recovery in 1 to 3 weeks, you wait for your own endothelial cells to migrate from the intact peripheral area to cover the central area from which the unhealthy cells were removed. After the cells migrate, they can begin removing fluid from the central cornea to help your vision clear without the use of donor tissue. We evaluated a novel growth factor and are assessing use of ROCK inhibitor eye drops to speed visual recovery after DSO. Learn more about DSO.
Determining correct dosing of anti-rejection medications in DMEK patients
The standard regimen of post-operative medications for cornea transplant recipients include antibiotics and relatively strong steroid eye drops taken to prevent your immune system from rejecting the new donor tissue. Having helped pioneer the DMEK technique and observing that DMEK had such a low risk of rejection, Dr. Price and the Cornea Research Foundation embarked on a series of studies to evaluate corticosteroid eye drop strength and dosing regimens over several years.
The goal of the studies were to protect the transplant from immunologic graft rejection while reducing the corticosteroid side effects, namely increased intraocular pressure (IOP). This is important because we know through tracking our transplant outcomes that 1 in 3 patients will experience increased IOP within one year using a standard steroid eye drop regimen. If left untreated, the pressure problems can lead to glaucoma and cause permanent vision loss.
Within the studies, we compared three different steroid medications of varying strength. Groups of patients were randomized to receive different steroid eye drops and were followed for one year. We evaluated the health of their transplant as well as any pressure changes within that year. Once patients reached the one year mark, they were given the option to either stay on the drop, switch to a lower dose if they were on the highest dose, or go off the drops entirely. Whichever they chose, we continued to examine the transplant and the eye pressure regularly.
We found that the risk of rejection was very low even when patients switched to a low-strength steroid eye drop at 1 month. So now we reduce steroid strength at 1 to 2 months after DMEK and that substantially reduces the risk of pressure elevation.
A few of those who discontinued steroid eye drops at one year (about 1 out of 17) experienced a rejection episode. In most cases it was mild and could be successfully treated by resuming steroids. Usually, the patient didn’t even realize they were having a rejection episode - our doctors detected it during one of the planned study examinations. Those who chose to continue using a low-strength eye drop did not experience any incidence of graft rejection episodes or pressure increases. Therefore our current recommendation is to stay on the low dose steroid long term.
We continue to monitor the progress of these individuals over the long run. We believe the findings from our anti-rejection medication studies will allow us to reduce the incidence of future glaucoma development in cornea transplant patients, particularly since many new DMEK surgeons are adopting our recommended dosing through the sharing of our results in leading ophthalmology publications.